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The prospective single-arm clinical trial to evaluate safety and efficacy of the training program for esophageal smooth muscle in patients with gastro-esopheal reflux disease.

The prospective single-arm clinical trial to evaluate safety and efficacy of the training program for esophageal smooth muscle in patients with gastro-esopheal reflux disease. - The clinical study of training program for esophageal smooth muscle in patients with gastro-esophageal reflux disease.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047829
Enrollment
20
Registered
2022-05-22
Start date
2022-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastro-esophageal reflux disease

Interventions

Swallowing training will be conducted 10 times at 7 to 10 seconds intervals in a supine position with their lower back raised. The program is performed twice a day for two weeks.

Sponsors

Nishijin Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Outpatients with GERD, whose symptom is refractory to conventional therapy including proton-pump inhibitor and exhibit its FSSG score beyond 7. Participants will be registered two years after the date of approval of this study. Informed consent is obtained from all subjects before enrollment in the study.

Exclusion criteria

Exclusion criteria: Difficulty evaluating their own condition because of dementia or mental disturbance. Heart or respiratory failure, spinal disease or other poor general condition. Disfunction of esophagus, stomach, pharyngolarynx affected by past operation or endoscopic treatment. Pregnancy or breast-feed.

Design outcomes

Primary

MeasureTime frame
The numerical value change of FSSG (Frequency Scale for the Symptoms of GERD) in the second week of training implementation.

Secondary

MeasureTime frame
The numerical value change of FSSG in the 4th or 8th week of training implementation. The quantity of proton pump inhibitor required in the 2nd, 4th, or 8th week of training implementation.

Countries

Japan

Contacts

Public ContactTomoko Nishimura

Nishijin Hospital Department of Internal Medicine

tnishimura@nishijinhp.com+81754618800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026